Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 March - 1 April 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Aquapel® 203
- Substance type: yellow fatty liquid
- Physical state: liquid
- Analytical purity: 89.9%
- Lot/batch No.: G12FY067
- Expiration date of the lot/batch: 12 June 2008
- Stability under storage conditions: stable
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, The Netherlands or Harlan, Gannat, France
- Age at study initiation: 7-12 weeks
- Weight at study initiation: 1614 - 2218 g
- Housing: Individually in labelled cages with perforated floors
- Diet (e.g. ad libitum): Pelleted diet for rabbits approximately 100 grams per day. Hay was provided at least three times a week.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.9 - 21.8
- Humidity (%): 33 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
4 hrs
Observation period:
Up to 14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2x3 cm (6 cm^2)
- % coverage: 100%
- Type of wrap if used: The test substance was applied to the skin of one flank, using a metalline patch# of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was cleaned of residual test substance using tap water.
- Time after start of exposure: 4 hrs


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hrs
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: score is mean value
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hrs
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: score is mean value
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hrs
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: score is mean value
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hrs
Score:
3.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: score is mean value
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hrs
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: score is mean value
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hrs
Score:
2.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: score is mean value
Irritant / corrosive response data:
Four hours exposure to 0.5 mL of AQUAPEL® 203 resulted in moderate to severe or severe erythema and moderate or severe oedema in the treated skin-areas of the three rabbits.
Reduced flexibility of the skin was noted in one animal 72 hours after exposure. Scaliness was noted in three animals between 72 hours and 14 days after exposure.
The skin irritation had resolved within 14 days after exposure in all animals, except for the scaliness in two animals.

No evidence of full thickness destruction of the skin or scar tissue was observed during the observation period, indicating that no corrosion of the skin had occurred by dermal application of AQUAPEL® 203 to the intact rabbit skin.
Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU